XORTX Receives Positive Feedback from FDA on COVID-19 Related Acute Kidney Injury

CALGARY, Alberta, Oct. 08, 2020 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (CSE: XRX) (OTCQB: XRTXF), a clinical stage pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce that the Company has received a positive response from the U.S. Food and Drug Administration (“FDA”) regarding its recent submission of a COVID-19 coronavirus pre-investigational new drug (“pre-IND”) meeting package providing the Company with a clear development path forward for XRx-101. XORTX’s submission to the FDA summarized current data supporting the XRx-101 program, XORTX’s plans to rapidly advance into clinical trials and further included questions related to XORTX’s development program details including proposed manufacturing, non-clinical and clinical steps. The FDA response provided clear feedback on the proposed plan and outlined the critical steps to test XRx-101 in patients with COVID-19 infection to treat acute kidney injury (“AKI”).
”We are very pleased with the collaborative feedback and tone of responses provided by the FDA and believe that we now have a robust understanding of the FDA’s requirement for clinical trial testing of XRx-101, NDA submission, and the focus of their review,” stated Dr. Allen Davidoff, CEO of XORTX, who added, “Based on responses from the FDA to our pre-IND package, we have clear guidance and the confidence in our decision to advance XRx-101 toward late stage clinical trial testing.”Looking to the near future, the Company anticipates results from the study currently being undertaken in partnership with Dr. Steven Coca, lead investigator and Associate Professor of Medicine at the Icahn School of Medicine and researchers at Mount Sinai in New York (see August 4, 2020 press release). The results of this study will guide future clinical trial design and conduct.The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the COVID-19 coronavirus at this time.About AKIAcute Kidney Injury (AKI) or Acute Renal Failure (ARF) refer to a stark decrease in kidney function, increased blood nitrogenous waste products and urea, as well as a dysfunction of blood volume and electrolyte balance. The acronyms AKI and ARF increasing recognize that small decreases in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased occurrence of symptoms and rate of death*.Coronavirus disease-19 (COVID-19) infection by SARS-CoV2 virus and the associated clinical disease symptoms, have resulted in more than 34 million infections worldwide and estimated mortality of ~3.9%. When first discovered, COVID-19 was described as a respiratory disease, however current understanding includes infection and injury to kidneys, heart, blood vessels, and the neurological system. AKI is a common complication affecting 40% of patients hospitalized with COVID-19, and injuring 20% sufficiently that acute dialysis is required. Of great concern is the finding that only 42% of patients with COVID-19 and AKI recovered baseline kidney function during hospitalization – a finding that may be a harbinger of a coming post-COVID kidney disease epidemic. (M. Fisher, et al, AKI in hospitalized patients with and without COVID-19: A comparison study. J. Am. Soc. Nephrol. (2020)).  * Source: https://www.uptodate.com/contents/definition-and-staging-criteria-of-acute-kidney-injury-in-adults).About XRx-101XORTX Therapeutics has developed XRx-101 a novel proprietary formulation of xanthine oxidase inhibitor for the treatment of COVID-19 induced AKI. XRx-101 can act to inhibit xanthine oxidase expression due to hypoxia, or tissue destruction, thereby preventing increased serum uric acid (SUA) concentration from reaching saturation levels at which uric acid crystals could trigger acute organ injury. In concept, XRx-101 may ameliorate the severity of COVID-19 infection comorbidity, mortality, and damage to kidneys.About XORTX Therapeutics Inc.XORTX Therapeutics Inc. is a biopharmaceutical company with three clinically advanced products in development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for Coronavirus / COVID-19 infection and XRx-221 is a clinical stage program for Type 2 Diabetic Nephropathy (T2DN). The Company has strong intellectual property rights and established proof of concept through independent clinical studies. XORTX is working to advance its clinical development stage products that target xanthine oxidase to inhibit production of uric acid. At XORTX Therapeutics, we are dedicated to developing medications to improve the quality of life and future of patients. Additional information on XORTX Therapeutics is available at www.xortx.com.For further information, please contact:The CSE has neither approved nor disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.
This news release includes forward looking statements that are subject to assumptions, risks and uncertainties. Statements in this news release which are not purely historical are forward looking statements, including without limitation any statements concerning the Company’s intentions, plans, estimates, beliefs or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs and expectations will prove to be accurate. The Company cautions readers that all forward looking statements, including without limitation those relating to the Company’s future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward looking statements. Readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance on forward looking statements. Any forward looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward looking statements, or to update the reasons why actual events or results could or do differ from those projected in the forward looking statements. The Company assumes no obligations to update any forward looking statements, whether as a result of new information, future events or otherwise.